Complete Applicable High-Risk AI Registration Requirements

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 49(1)

   Upcoming

   Register Annex III High-Risk AI Providers and Systems in the EU Database

   Tracker Networks Guidance

   Before market placement or putting into service, register the provider or authorised representative and the applicable Annex III high-risk AI system in the EU database.

   Official text

   1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to in Article 71.

   Suggested controls

   • CE Marking and AI Registration

     Apply required CE marking and complete applicable EU or national AI registration before market placement, service or qualifying use.

   Related risks

   • AI Declaration, CE Marking or Registration Failure

     Required declarations, CE marking or EU/national database registrations may be missing, inaccurate, outdated or completed too late.

2. Article 49(2)

   Upcoming

   Register Annex III AI Systems Assessed as Not High-Risk

   Tracker Networks Guidance

   Before market placement or putting into service, register the provider or authorised representative and any Annex III system the provider has concluded is not high-risk under Article 6(3).

   Official text

   2. Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.

   Suggested controls

   • High-Risk AI Classification Assessment

     Document whether potentially high-risk AI systems meet applicable classification criteria and any relied-upon exception.

   • CE Marking and AI Registration

     Apply required CE marking and complete applicable EU or national AI registration before market placement, service or qualifying use.

   Related risks

   • Incorrect AI Risk Classification

     An AI system may be incorrectly classified, causing applicable high-risk obligations or other requirements to be missed.

   • AI Declaration, CE Marking or Registration Failure

     Required declarations, CE marking or EU/national database registrations may be missing, inaccurate, outdated or completed too late.

3. Article 49(3)

   Upcoming

   Register Public-Authority Use of Applicable Annex III High-Risk AI

   Tracker Networks Guidance

   Before putting the system into service or using it, qualifying public-authority deployers must register themselves, select the system and register its use in the EU database.

   Official text

   3. Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.

   Suggested controls

   • Public-Authority High-Risk AI Registration Check

     Confirm required registration before public-authority use and block unregistered systems.

   • CE Marking and AI Registration

     Apply required CE marking and complete applicable EU or national AI registration before market placement, service or qualifying use.

   Related risks

   • Improper High-Risk AI Deployment

     A deployer may operate high-risk AI contrary to provider instructions, without qualified oversight, suitable inputs or required monitoring.

   • AI Declaration, CE Marking or Registration Failure

     Required declarations, CE marking or EU/national database registrations may be missing, inaccurate, outdated or completed too late.

4. Article 49(4)-(5)

   Upcoming

   Use the Required Restricted or National Registration Route for Specified Annex III Systems

   Tracker Networks Guidance

   Use the secure non-public EU database section for the specified law-enforcement, migration, asylum and border-control categories and national registration for Annex III point 2 systems, as applicable.

   Official text

   4. For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in: (a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9; (b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII; (c) Section C, points 1 to 3, of Annex VIII; (d) points 1, 2, 3 and 5, of Annex IX. Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph. 5. High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.

   Suggested controls

   • CE Marking and AI Registration

     Apply required CE marking and complete applicable EU or national AI registration before market placement, service or qualifying use.

   Related risks

   • AI Declaration, CE Marking or Registration Failure

     Required declarations, CE marking or EU/national database registrations may be missing, inaccurate, outdated or completed too late.